This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.
This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)
20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging
Greenebaum Cancer Center - University of Maryland Medicine
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Maximum tolerated dose (MTD)
Time frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
Pharmacokinetic and pharmacodynamic parameters
Time frame: Obtained during the first cycle of therapy on Days 1 and 3
Anti-tumor activity
Time frame: Initial dose of study therapy to disease progression
Uptake of 99mTc-Ec20 in tumors and normal tissues
Time frame: 1-2 hours post-administration of 99mTc-EC20
Safety and tolerability
Time frame: Initiation of study therapy through 30 day post last dose of study therapy
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